Health BehaviorNCT00452816
Marketing Workplace Chronic Disease Prevention
A study testing Workplace Solutions Consulting approach and Delayed intervention in people with Health Behavior and Chronic Disease, run by University of Washington at 1 site in United States.
Trial summary
The objective of the project is to understand how best to help mid-size employers adopt evidence-based chronic disease prevention practices that improve employee health behaviors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Behavior, Chronic Disease
- What is being tested?
- Workplace Solutions Consulting approach and Delayed intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Corporate size equal to 100 to 999 part-time and full-time employees (excluding seasonal and temporary workers)
- Headquarters located in King County, Washington, and in a zip code within a 30 mile radius of the research center
- Within an industry with an average annual salary below the median annual salary for King County, Washington (defined by 3-digit NAICS code)
- 50% or more employees are age 35 or older
Who cannot join
- Do not offer health insurance to full-time employees
- In existence for less than 3 years
- No physical address to which employees report
- Current or previous participation in other workplace health promotion study
- Recent refuser or non-responder for other current workplace health promotion study
- Current participant in other American Cancer Society employer program
- Not willing to be randomized to intervention or comparison group
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the project is to understand how best to help mid-size employers adopt evidence-based chronic disease prevention practices that improve employee health behaviors.
Read the detailed description
Employers have the incentive and the means to play a key role in chronic disease prevention. The incentive - employers need to control the costly and growing burden of chronic diseases among their employees. The means - employers purchase 94% of private health insurance, and employees spend one third of their lives in the workplace, where they often eat, move, socialize, and smoke. Over the past 5 years, the CDC and the Task Force on Community Preventive Services have recommended a number of chronic disease prevention practices. Among these, we have identified 17 practices that employers should adopt. These practices include health insurance benefits, workplace policies, and workplace programs, and aim at increasing employees' disease screening, healthy eating, influenza immunization, physical activity and tobacco cessation. Unfortunately, employer surveys reveal low adoption of these practices.
Working with the American Cancer Society, our research team from the University of Washington has developed and pilot-tested an innovative consulting intervention to increase adoption of these practices. Our two-stage intervention is comprehensive yet tailored by employer feedback.
The intervention:
- markets the "business case" that employers can help control health-care costs and productivity losses through adoption of these practices
- enables implementation by providing tools for each practice.
In this proposal, our primary aim is to test this intervention in a randomized, controlled trial among 48 medium-sized employers with a high proportion of socioeconomically disadvantaged employees in the Puget Sound area. Our primary outcome is change in employer practices as measured by survey and validated by audit and contract and policy review.
Our secondary aims include:
- development and pilot-testing of an employee-level health risk behavior survey
- cost analysis and assessment of feasibility of our intervention
- assessment of employees' preference for different message sources and message appeals.
Our multidisciplinary research team includes business, communication, and public health faculty and has more than 10 years of experience in both chronic disease prevention and working with business. If successful, our team's approach has broad applicability to other public health problems.
- Conditions
- Health Behavior, Chronic Disease
- Being tested
- Workplace Solutions Consulting approach, Delayed intervention
- Keywords
- Chronic Disease, Employer Health Costs, Health Promotion, Insurance Benefits, Marketing of Health Services, Mass Screening, Prevention & Control, Tobacco Use Cessation, Workplace
- Medical subject headings
- Health Behavior, Chronic Disease, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Workplace Solutions Consulting approachBehavioural
Consulting process includes:
- baseline measure of best practices
- gap analysis and recommendations reporting
- delivery of "solution set" toolkits for each practice chosen for implementation
Delayed interventionBehavioural
Abbreviated version of the Workplace Solutions Consulting process applied in the intervention group
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention Group - Workplace Solutions Consulting Receives: Behavioral: Workplace Solutions Consulting approach |
| 2 | Active comparator | Delayed Intervention Receives: Behavioral: Delayed intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in employer practices in health benefits, policies and programs
Measured: 15 month follow-up survey
Secondary outcomes (2)
Development and pilot-testing of an employee-level health risk behavior survey
Measured: within 12 months of recruitment completion
Cost analysis and assessment of feasibility of this intervention
Measured: within 15 months of recommendations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionAug 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, American Cancer Society, Inc.
- Investigators
- Jeffrey R Harris, MD, MPH, MBA, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452816
- Sponsor's protocol ID
- 06-4829-E/G 01
- Other IDs
- CDC Grant 1 PO1 CD000249-01
- Status last verified
- Nov 2009
- First submitted
- 26 Mar 2007
- Last updated
- 20 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hannon PA, Harris JR, Sopher CJ, Kuniyuki A, Ghosh DL, Henderson S, Martin DP, Weaver MR, Williams B, Albano DL, Meischke H, Diehr P, Lichiello P, Hammerback KE, Parks MR, Forehand M. Improving low-wage, midsized employers' health promotion practices: a randomized controlled trial. Am J Prev Med. 2012 Aug;43(2):125-33. doi: 10.1016/j.amepre.2012.04.014.
PubMed 22813676
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marketing Workplace Chronic Disease Prevention
- ClinicalTrials.gov ID
- NCT00452816
- Acronym / sponsor ID
- 06-4829-E/G 01
- Conditions
- Health Behavior, Chronic Disease
- Keywords
- Chronic Disease, Employer Health Costs, Health Promotion, Insurance Benefits, Marketing of Health Services, Mass Screening, Prevention & Control, Tobacco Use Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, American Cancer Society, Inc.
- Study start
- Apr 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 28 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the project is to understand how best to help mid-size employers adopt evidence-based chronic disease prevention practices that improve employee health behaviors.
Detailed description
Employers have the incentive and the means to play a key role in chronic disease prevention. The incentive - employers need to control the costly and growing burden of chronic diseases among their employees. The means - employers purchase 94% of private health insurance, and employees spend one third of their lives in the workplace, where they often eat, move, socialize, and smoke. Over the past 5 years, the CDC and the Task Force on Community Preventive Services have recommended a number of chronic disease prevention practices. Among these, we have identified 17 practices that employers should adopt. These practices include health insurance benefits, workplace policies, and workplace programs, and aim at increasing employees' disease screening, healthy eating, influenza immunization, physical activity and tobacco cessation. Unfortunately, employer surveys reveal low adoption of these practices.
Working with the American Cancer Society, our research team from the University of Washington has developed and pilot-tested an innovative consulting intervention to increase adoption of these practices. Our two-stage intervention is comprehensive yet tailored by employer feedback.
The intervention:
- markets the "business case" that employers can help control health-care costs and productivity losses through adoption of these practices
- enables implementation by providing tools for each practice.
In this proposal, our primary aim is to test this intervention in a randomized, controlled trial among 48 medium-sized employers with a high proportion of socioeconomically disadvantaged employees in the Puget Sound area. Our primary outcome is change in employer practices as measured by survey and validated by audit and contract and policy review.
Our secondary aims include:
- development and pilot-testing of an employee-level health risk behavior survey
- cost analysis and assessment of feasibility of our intervention
- assessment of employees' preference for different message sources and message appeals.
Our multidisciplinary research team includes business, communication, and public health faculty and has more than 10 years of experience in both chronic disease prevention and working with business. If successful, our team's approach has broad applicability to other public health problems.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Workplace Solutions Consulting approachIntervention Group - Workplace Solutions Consulting |
| 2 | Active comparator | Behavioral: Delayed interventionDelayed Intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Corporate size equal to 100 to 999 part-time and full-time employees (excluding seasonal and temporary workers)
- Headquarters located in King County, Washington, and in a zip code within a 30 mile radius of the research center
- Within an industry with an average annual salary below the median annual salary for King County, Washington (defined by 3-digit NAICS code)
- 50% or more employees are age 35 or older
Key exclusion criteria (7 listed)
- Do not offer health insurance to full-time employees
- In existence for less than 3 years
- No physical address to which employees report
- Current or previous participation in other workplace health promotion study
- Recent refuser or non-responder for other current workplace health promotion study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Workplace Solutions Consulting approachConsulting process includes: 1. baseline measure of best practices 2. gap analysis and recommendations reporting 3. delivery of "solution set" toolkits for each practice chosen for implementation | Behavioural | Intervention |
| Delayed interventionAbbreviated version of the Workplace Solutions Consulting process applied in the intervention group | Behavioural | 2 |
Primary outcome
Change in employer practices in health benefits, policies and programs
Time frame: 15 month follow-up survey
2 secondary outcomes
Development and pilot-testing of an employee-level health risk behavior survey
Time frame: within 12 months of recruitment completion
Cost analysis and assessment of feasibility of this intervention
Time frame: within 15 months of recommendations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2009.
- Derived from this study: PubMed 22813676Hannon PA, Harris JR, Sopher CJ, Kuniyuki A, Ghosh DL, Henderson S, Martin DP, Weaver MR, Williams B, Albano DL, Meischke H, Diehr P, Lichiello P, Hammerback KE, Parks MR, Forehand M. Improving low-wage, midsized employers' health promotion practices: a randomized controlled trial. Am J Prev Med. 2012 Aug;43(2):125-33. doi: 10.1016/j.amepre.2012.04.014.
- Click here for more information about this study: Marketing Workplace Chronic Disease Prevention (The Workplace Solutions Project)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey R Harris, MD, MPH, MBA principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Workplace Solutions Consulting approach and Delayed intervention in people with Health Behavior and Chronic Disease, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in employer practices in health benefits, policies and programs (time frame: 15 month follow-up survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00452816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2009.